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Agency for Toxic Substances and Disease Registry National Center for Environmental Health
Centers for Disease Control and Prevention
Evidence to Recommendations Framework: Routine Vaccination with Jynneos for Adolescents at
Risk of Mpox
Faisal Syed Minhaj, PharmD, MPH Poxvirus and Rabies Branch Centers for Disease Control and Prevention Advisory Committee on Immunization Practices April 15, 2025
Does ACIP recommend vaccination* with the 2-dose †JYNNEOS vaccine series
for persons aged 12–17 years at risk for mpox §?EtR Question
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
1. Gay, bisexual, and other men who have sex with m en (MSM), or a person who has sex with
MSM, who in the past 6 months have had one of the f ollowing:
•A new diagnosis of ≥ 1 sexually transmitted disease
•More than one sex partner
•Sex at a commercial sex venue
•Sex in association with a large public event in a g eographic area where mpox
transmission is occurring
2. Sexual partners of persons with the risks descri bed in above
3. Persons who anticipate experiencing any of the a bove
Evidence to Recommendation Domains
Question(s) EtR Domain
•Is the problem of public health importance? Public Health Problem
•How substantial are the desirable anticipated effec ts?
•How substantial are the undesirable anticipated eff ects?
•Do the desirable effects outweigh the undesirable e ffects? Benefits and Harms
•Does the target population feel the desirable effec ts are large relative to the
undesirable effects?
•Is there important uncertainty or variability in ho w much people value the
main outcome? Values
•Is the intervention acceptable to key stakeholders? Acceptability
•What would be the impact on health equity? Equity
•Is the intervention feasible to implement? Feasibility
•Is the intervention a reasonable and efficient allo cation of resources? Resource Use
EtR Domain: Public Health Problem
Mpox current situation
Jynneos vaccine coverage in the United States among people
at risk for mpox – June 2022 through September 2024
Overall vaccine coverage
1-dose: 42.2% and 2-dose: 26.2 %
Cumulative Monkeypox virus infections relative to
2022, by immunity level — United States, 2023
>50% is needed
to significantly
decrease the risk of
large outbreaks Cumulative
monkeypox
virus
infections,
relative to
2022
% Population at increased mpox risk with 1 or 2 dos es of Jynneos
Pollock ED. MMWR MorbMortal WklyRep 2023;72:568–573.
https://www.cdc.gov/cfa-modeling-and-forecasting/mp ox-gbmsm-
technical-brief/nov24-update/
U.S. mpox case trends in adolescents and children,
May 2022 through March 2025
Case Count Age
group
92 12-17
17 6-11
23 1-5
15 <1
147 Total
Are outbreaks of mpox of public health importance?
No Probably no Uncertain Yes
Varies
Probably Yes
EtR Domain: Benefits and Harms
•Adolescent arm met pre-specified criteria for non-inferior ity
-GMT ratio of adolescents to adults was 1.60 (CI 1.3 2, 1.95)
•Vaccine was safe and well tolerated in adolescents
-Solicited systemic and local AEs were similar betwe en adolescents and adults
•Systemic: 74% (CI 69, 79) vs 73% (CI 66, 79)
•Local: 88% (CI 84, 91) vs 91% (CI 87,95)
-Unsolicited related AEs: mainly injection site rela ted
-Dizziness in adolescents is common with vaccine adm inistration in this age group
and is not likely to represent a safety concern Adolescent safety and immunogenicity study summary
•Vaccine adverse event reporting system (VAERS) 1
-At least 1,245 vaccinees nationwide
-One report of syncope
-Three reports of unspecified mild local and systemi c reactions
•VSD 2
-88 vaccinees
-No adverse events of special interest observed
•V-safe 1
-No participants were <18 years of age
•EIND 3
-57 vaccinees
-21% reported local or systemic reactions. No seriou s adverse events were reported Adverse events among individuals <18 years of age
1) https://pubmed.ncbi.nlm.nih.gov/38647241/ 2) htt ps://pubmed.ncbi.nlm.nih.gov/39565485/ 3) https://p ubmed.ncbi.nlm.nih.gov/36480476/
How substantial are the desirable anticipated effects
Minimal Small Moderate Large
Don’t Know Varies
How substantial are the undesirable anticipated effects
Minimal Small Moderate Large
Don’t Know Varies
Do the desirable effects outweigh the undesirable ef fects?
Favors Intervention Favors Comparison Favors Both
Favors Neither Unclear
EtR Domain: Values
•NIH rapidly completed trial recruitment
•Participants were supportive in participating to help frien ds
•Adolescent Medicine Trials Network for HIV/AIDS Intervent ions (ATN)
youth advisors were surveyed and 12/13 respondents we re supportive of
vaccination
•When an outbreak occurred (i.e., 2022 global outbreak) , pediatric close
contacts were vaccinated Values Considerations
JYNNEOS first doses administered to children 17 yea rs
and younger by sex May 2022 – September 2024
Persons with no age data available were removed fro m the analysis Total first doses Age group
798 12-17
391 6-11
293 1-5
150 <1
1,632 Total
Does the target population feel that the desirable effects are large relative to the undesirable effec ts?
No Probably no Uncertain Yes
Varies
Probably Yes
Is there important uncertainty about or variability in
how much people value the main outcomes?
Important uncertainty or variability Possibly important uncertainty or variability
No known undesirable outcomes
Probably no important uncertainty or variability No important uncertainty or variability
EtR Domain: Acceptability
•Mothers from the survey do not view their children at r isk for mpox.
-However, the intent to vaccinate is higher than exp ected.
•Vaccines were primarily given to adolescents both through public health
and STI clinics.
•Among 21 surveyed ATN providers who provide care for at-risk adolescents:
-Over half already offer the mpox vaccine.
-95% would recommend mpox vaccines for eligible pati ents and do not have
concerns about recommending the vaccine.
-Majority expressed challenges associated with offer ing the vaccine; most
common concern was financial cost to the clinic. Summary of Acceptability data
Is the intervention acceptable to key stakeholders?
No Probably no Uncertain Yes
Varies
Probably Yes
EtR Domain: Health Equity
Vaccine administrations* and cases in adolescents by
race and ethnicity, May 2022 – March 2025
n=92 n=798
*Vaccine administration through September 2024, Case da ta
through March 2025 +Includes 3 mpox cases indicating Multiple races. Mul tiple
races was not reported for vaccine administration da ta.
If Hispanic or Latino was indicated for ethnicity, Race/ethnicity is indicated as Hispanic or Latino; if Hispanic or
Latino ethnicity was not indicated, Race/ethnicity is indicated
as Race Vaccine Administrations Mpox Cases
+
•No groups or settings were disadvantaged by recommend ation for JYNNEOS
use during mpox outbreaks.
•Immunogenicity is the same for immunocompetent persons 12-17 years.
•Implementation of vaccine should assure equitable access.
•Endorsement by ACIP could facilitate broad acceptance o f recommendation
(e.g., insurance, health departments, pharmacies). Health Equity
What would be the impact on health equity?
Reduced Probably Reduced Probably no impact Increased
Varies
Probably Increased
Don’t know
EtR Domain: Feasibility
•Wide range of vaccinators can administer vaccine (pediatr icians,
pharmacists, public health nurses)
•Wide range of potential facilities: public health, STI clinic, a dolescent health
clinic, pediatrician offices
•Same Immunization Information Systems (IIS) requirement s and reporting
infrastructure as other vaccines
•Limitations to access
-Poor access in rural communities
-Cost of vaccine and 10 vial minimum ordering quanti ty could hinder practices
stocking vaccine
-Pediatricians may defer to STI/adolescent clinics Feasibility Considerations
•Two doses, 28 days apart requires follow up and reminde rs
•JYNNEOS, once thawed/refrigerated, is good for either 4 or 8 weeks,
allowing time to schedule a second dose.
•Frozen storage is ~18 months Feasibility Considerations
Is the intervention feasible to implement?
No Probably no Uncertain Yes
Varies
Probably Yes
EtR Domain: Resource Use
•JYNNEOS is commercially available
-Similar mechanisms for billing/reimbursement
•Medicaid/Medicare/317 funding/VFC
•Generally, vaccines are a good use of resources
•Cost-effectiveness of vaccination in adolescents is uncer tain Resource Use
Is the intervention a reasonable and efficient allocation of resources?
No Probably no Uncertain Yes
Varies
Probably Yes
Balance of Consequences
Summary of Work Group Interpretation of EtR Domains
Work Group Interpretation EtR Domain
Yes Public Health Problem Benefits and Harms
Large Benefits
Small Harms
Favors intervention Benefit>Harm?
Values
Probably yes Desirable>Undesirable?
Possibly important OR probably no important
uncertainty or variability Uncertainty?
Probably yes Acceptability
Probably increased Equity
Probably yes Feasibility
Probably yes Resource Use
Balance of consequences
There is
insufficient evidence to determine the balance of consequences Desirable consequences clearly
outweigh
undesirable consequences in most settings Desirable consequences
probably
outweigh
undesirable consequences in most settings The balance
between the desirable and undesirable consequences is closely
balanced or
uncertain Undesirable consequences
probably
outweigh
desirable consequences in most settings Undesirable consequences clearly
outweigh
desirable consequences in most settings
ACIP recommends vaccination* with the 2-dose †JYNNEOS vaccine series for
persons aged 12–17 years at risk for mpox §?Proposed Recommendation 2
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
1. Gay, bisexual, and other men who have sex with m en (MSM), or a person who has sex with
MSM who in the past 6 months have had one of the fo llowing:
•A new diagnosis of ≥ 1 sexually transmitted disease
•More than one sex partner
•Sex at a commercial sex venue
•Sex in association with a large public event in a g eographic area where mpox
transmission is occurring
2. Sexual partners of persons with the risks descri bed in above
3. Persons who anticipate experiencing any of the a bove
Tentative timeline for ACIP discussions and votes
ACIP Meeting:
Presentation
of two EtR
April 2025 ACIP Meeting:
Voting on two
EtR
June 2025 Continue monitoring
mpox epidemiology
and vaccine
recommendations
Ongoing
The findings and conclusions in this report are tho se of the authors and do not
necessarily represent the official position of the Centers for Disease Control and
Prevention Thank you